BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-200 S PLUS

    MDR report key: 14459549 · Received May 20, 2022

    Report

    Report Number
    0002936921-2022-00005
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 6, 2022
    Report Date
    July 18, 2022
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    UDI-DI
    04987669101452
    PMA / PMN Number
    K203130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 05/19/2022, THE DEVICE EVALUATION IS PENDING. NIDEK INC SENIOR PRODUCT MARKETING MANAGER AND SENIOR SALES & MARKETING MANAGER ARE COMMUNICATING WITH THE USER FACILITY TO SCHEDULE A VISIT. FOLLOW-UP MDR WILL BE SUBMITTED ONCE NIDEK INC RECEIVES FURTHER INFORMATION FROM THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    NIDEK INC. DETERMINED THAT THE CAUSE OF CUSTOMER REPORTED ISSUE "PITTING LENS" WAS INCONCLUSIVE. NIDEK INC FIELD SERVICE ENGINEER (FSE) POWERED ON SYSTEM AND FOUND IN WORKING ORDER. SHOT COUNTER = 1,298. MEASURED 2.8MJ AT 3.0MJ SETTING. MEASURED 4.7MJ AT 5.0MJ SETTING. OPTICAL BREAKDOWN = 1.5MJ. BEAM COINCIDENCE CHECKED OK. FSE PERFORMED FOLLOWING SERVICE ACTIVITIES AS PREVENTIVE MEASURES: O PERFORMED COMPLETE INSPECTION OF THE LASER SYSTEM. O AUTO-CALIBRATION OF THE PFN VOLTAGE = 465VDC. O CLEANED OBJECTIVE LENS AND OCULARS. O FOR GOOD MEASURE, CALIBRATED LASER ENERGIES: 0.3MJ, 0.5MJ, 1.0MJ, 3.0MJ, 5.0MJ, 7.0MJ, AND 10.0MJ IN SINGLE, DOUBLE, AND TRIPLE BURST MODES. O VERIFIED: YAG/AIMING COINCIDENCE AND OFFSET FOCUS SHIFT IS PROPER FOR 0 - 500 MICRONS ANTERIOR AND POSTERIOR. YAG ENERGY OUTPUT IS IN SPEC 0.2 - 10.0MJ SINGLE BURST, 0.4 - 20.0MJ DOUBLE BURST, 0.6 - 30.0MJ TRIPLE BURST. OPTICAL BREAKDOWN = 1.4MJ. SYSTEM OPERATIONAL AT ALL SETTINGS AND MODES. ALL TEST SHOTS AND BEAM PROFILE CHECKED OK. THE SYSTEM WAS TESTED AND INSPECTED. FSE VERIFIED THAT THE SYSTEM IS OPERATIONAL. THE REPORTED UNIT PASSED FINAL INSPECTION PER INSPECTION DISTRIBUTION ACCEPTANCE RECORD #IDAR-2021-0269, AND INSTALLATION AND IN-SERVICE TRAINING WAS PERFORMED PROPERLY PER INS-2021-0144. THERE WAS NO SUPPORTING EVIDENCE TO POINT TO MACHINE, MAN, METHOD/PROCESS AND MATERIAL AS THE CAUSE OF THE REPORTED COMPLAINT ISSUE. AS A PRECAUTION,RG-093-2 YC-200/ YC-200 S PLUS QUICK REFERENCE GUIDE WILL BE SENT OUT TO THE CUSTOMER TO REMIND CUSTOMER OF SAFETY INFORMATION IN YC-200 OPERATOR'S MANUAL TO MITIGATE AGAINST POTENTIAL OCCURRENCE OF PITTING LENSES. PER DEVICE EVALUATION, FSE VERIFIED THAT THE SYSTEM IS OPERATIONAL. BASED ON THE HISTORICAL DATA REVIEW OF 1 YEAR, THERE ARE 6 RELATED SIMILAR COMPLAINTS BUT NO DEVICE MALFUNCTION FOUND, THEREFORE NO TREND IDENTIFIED. INVESTIGATION IS CLOSED.

    Description of Event or Problem · 0

    NIDEK INC RECEIVED A TELEPHONE CALL FROM THE CUSTOMER TO REPORT THAT THEY OBSERVED PITTING LENS WHEN FIRED THE LASER FOR THE FIRST TIME. FOCUS SHIFT SETTING WAS 250 POSTERIOR. THE PITTING LENS HAPPEN LAST WEEK, AND THE DOCTOR INFORMED THE TECHNICIAN AT THE CUSTOMER SITE TO REPORT PITTING LENS TO NIDEK INC ON (B)(6) 2022, AND NIDEK INC RECEIVED A TELEPHONE CALL ON 05/09/2022. NO INJURY WAS REPORTED FROM THE CUSTOMER. DEVICE EVALUATION IS PENDING. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200 CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR CAPSULOTOMY, PUPILLARY MEMBRANECTOMY, IRIDOTOMY (HOLE IN THE IRIS) AND SELECTIVE LASER TRABECULOPLASTY. THIS DEVICE USES PASSIVE Q-SWITCHING FOR LASER OSCILLATION. WITH PASSIVE Q-SWITCHING, THE DEVICE FIRST ACCUMULATES SUFFICIENT ENERGY WITHIN THE LASER CAVITY THEN EMITS LASER PULSES OF HIGH PEAK POWER FOR EXTREMELY SHORT DURATIONS BY USE OF THE Q-SWITCHED OPTICAL ELEMENT WHICH CHANGES BETWEEN TRANSPARENT AND OPAQUE ACCORDING TO THE ACCUMULATION OF ENERGY. YC-200 DEVICE IS EQUIPPED WITH YAG MODE FUNCTION ONLY. YC-200 S PLUS DEVICE IS EQUIPPED WITH YAG AND SLT MODE FUNCTIONS.

    Description of Event or Problem · 0

    PLEASE SEE INITIAL MDR SUBMITTED ON 05/19/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368968 YC-200 S PLUS YAG LASER HQF NIDEK CO. LTD. YC-200 04987669101452

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other